Position Summary:
The Equipment Validation Specialist is responsible for supporting the implementation, validation, maintenance, and continuous improvement of laboratory automation and robotic systems within a regulated GxP environment. This role partners closely with laboratory operations, automation engineers, quality, validation, and IT stakeholders to ensure robotic platforms operate reliably, compliantly, and efficiently while enabling future digital and AI-driven laboratory capabilities.
Key Responsibilities:
Automation & Robotics Implementation
- Support implementation and integration of automation solutions for laboratory platform technologies.
- Assist in connecting automated systems and robotic equipment to laboratory workflows and operational requirements.
- Configure, test, and verify robotic and automation systems to ensure intended performance.
- Collaborate with cross-functional teams to deploy new automation capabilities supporting laboratory modernization initiatives.
Validation & Compliance
- Author, execute, and maintain equipment validation documentation, including qualification and testing protocols.
- Develop and manage Change Control documentation associated with automation systems.
- Ensure automation platforms remain in a validated state throughout their lifecycle.
- Support compliance with FDA regulations, GxP requirements, and company quality standards.
- Participate in audits, inspections, and quality reviews as required.
System Lifecycle Management
- Execute lifecycle management activities for automated laboratory systems.
- Monitor system performance and support preventative maintenance strategies.
- Maintain documentation, system inventories, and validation records.
- Support upgrades, enhancements, and continuous improvement efforts.
Troubleshooting & Investigations
- Diagnose and resolve equipment, automation, and system integration issues.
- Perform root cause analysis and implement corrective and preventive actions (CAPA).
- Support investigations involving automation systems and develop corrective actions.
- Partner with vendors and internal stakeholders to address technical issues and system performance concerns.
Data Analytics & Digital Enablement
- Develop reporting, analytics, and visualization solutions supporting laboratory operations and business processes.
- Leverage operational data to identify opportunities for process optimization and performance improvements.
- Support evaluation and deployment of emerging AI/ML capabilities as they become available for laboratory automation platforms.